Pemefolacianine for IMI of Lung Cancer

Conditions

• Lung Cancer (Locally Advanced or Metastatic)

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Pemefolacianine Cohort 1 in Part A — DRUG
  Enrolled subjects arrive at the infusion center for their infusions up to 8-36hours before the scheduled surgery to receive their injection of Pemefolacianine for Injection. cohorts 1 patients will receive dose of 0.02 mg/kg
• Pemefolacianin Cohort 2 in Part B — DRUG
  Enrolled subjects arrive at the infusion center for their infusions up to 8-36hours before the scheduled surgery to receive their injection of Pemefolacianine for Injection. cohorts 2 patients will receive dose of 0.04 mg/kg

Study Details

The aim of this Phase 1b study is to investigate the safety and fluorescence signal of a single dose of Pemefolacianine for Injection, a novel fluorescence imaging agent developed by Nanjing Nuoyuan Medical Devices Co., Ltd (Nuoyuan Medical), administered by slow intravenous (IV) in patients undergoing surgical thoracoscopy and/or RATS (Robot-Assisted Thoracoscopic Surgery) resection of lung cancer. Safety is the primary objective of this study, followed by evaluation of the fluorescence signal as it relates to dose level and dosing time interval which will not be used for decision-making in the surgical resection in this study.

Key Dates

First listed

Aug 19, 2026

Start date

Mar 11, 2026

Status verified

Mar 2026

Primary completion

Mar 11, 2027

Completion

Mar 11, 2027

Study Design

Enrollment

12 participants (estimated)

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Experimental: Pemefolacianine Cohort 1
  The dose of Pemefolacianine for Injection planned to be administered to the first cohort of patients is 0.02 mg/kg.
• Experimental: Pemefolacianine Cohort 2
  The patients in second cohort were planned to receive dose Pemefolacianine for Injection at 0.04 mg/kg.

Primary Outcome Measure

Number of participants with treatment-related adverse events as assessed by CTCAE v5.0 [ Time Frame: Day 1 through Day 30 ]

Locations (1)

Find similar trials in Philadelphia, PA

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